The present invention relates to highly inert, single-dose packagings for forms of administration in film or foil form and transdermal therapeutic systems (TTSs), which are easy to open, but are nevertheless childproof.
The present invention also comprises a method for producing the single-dose packagings according to the invention which is distinguished by economical use of material.
Drug packagings have to perform a number of tasks. On the one hand, as a single dose, a packaging is intended for example to ensure that only a specific dose is ever taken at one time and that the taking of more than one dose is avoided.
On the other hand, the drug is also intended to be protected by the packaging from environmental influences such as light and moisture, which often lead to the active substance breaking down, and consequently to the medicament becoming unusable. Specifically in the case of containers that contain a number of dose units, here there is the problem that repeated opening of the container for the removal of a single dose adversely impairs the quality of the drug preparation, this impairment being all the greater the more sensitive the form of administration is with respect to mechanical and physical-chemical loads. Particularly drugs presented in film form impose particular requirements on the packaging, since the films are sensitive to physical-chemical influences (for example light, moisture or oxygen) on account of the large surface area and to mechanical loads on account of their structure.
In addition, the packagings are intended to prevent the drugs from being accessible to children, to take them unintentionally or administer the medication themselves.
On the one hand, a particular problem in the design of such secure drug packagings is that the packaging is intended to provide maximum security against unintentional self-medication, in particular by children driven by curiosity to open the packagings and confusing the medicaments, which are often colored and aromatized to mask the bad taste and/or smell of the active substances, for candy or other confectionery and taking them or applying the TTSs contained in the course of play.
On the other hand, however, the opening of the packaging is intended to be easy enough that adults, particularly including elderly persons and persons with motor difficulties, can open these packagings without any problems and that good compliance is ensured in the taking of the drugs.
As to be expected from the nature of the problem described above, a solution for achieving these objectives appears elusive, since children often approach the task of opening the packaging with great perseverance, ingenuity and intuition, while adult users often neglect the requisite study of the instructions or explanatory pictograms and unnecessarily take a knife or scissors to open the packaging, or else in the worst case fail to take the medication because of the difficulties in opening the packaging if these utensils do not happen to be to hand, with the result that patient compliance falls.
A further problem with single-dose packagings for forms of administration in film or foil form and transdermal therapeutic systems is that the surface area of the single dose is quite large in relation to the content of active substance in comparison with other forms of administration such as tablets or suppositories and cannot be reduced by bending and folding.
The size of the film consequently determines the size of the packaging. Furthermore, on account of the already discussed sensitivity of the films, the use of expensive high-barrier foils (high-barrier films), which can be subjected to mechanical loads and at most allow slight permeation of gases and moisture, is called for in order to ensure the necessary protection of the form of administration.
This gives rise to the disadvantage that both the upper side and the underside of the large-area form of administration has to be covered with a foil, which involves high expenditure on material and, as a result of the expensive foils, leads to high packaging costs, which may significantly increase the costs of the single dose and bring about an extremely unfavorable ratio of packaging costs to product costs. It should be mentioned in this respect that childproof packagings in particular often require additional expenditure on material in making them childproof.
The following proposals for easy-to-open, but childproof packagings are known from the prior art.
The laid-open patent application DE 10 2004 047 445 A1 discloses a non-reclosable packaging for harmful products, which has two packaging material elements arranged one lying on top of the other, a first area portion, at the peripheral edge or edges of which the two packaging material elements are releasably joined to one another, with at least one cavity that is enclosed on all sides for receiving the packaged product being formed between the two packaging material elements, and a second area portion, lying outside the first area portion or adjacent thereto, at the peripheral edge or edges of which the two packaging material elements are releasably joined to one another. At least one of the two packaging material elements is provided with at least one structure, which runs within the second area portion and makes it possible for the element or packaging material element or elements to be torn into.
The laid-open patent application US 2006/0023976 A1 describes peelable pouches for one or more doses of a drug in which two sheets of packaging material are peripherally sealed to one another, and which are provided in the region of the sealed peripheral edge with a surface structure which allows the pouch to be torn into and is crossed by a folding line. The peripheral edge of the pouch must be bent along the folding line in order that it can be torn into at the surface structure and opened.
The laid-open patent application. DE 10 2006 041 921 A1 describes a childproof packaging for films containing active substances, which comprises a carrier layer and a top layer releasably joined to the latter and, in a paired arrangement, two opposing area regions which are separated from one another by a web and within which the top layer is not joined to the carrier layer, whereby two spaces that are separate from one another and enclosed on all sides are formed for receiving said films in pairs. Within said web there is a further area region, in which the carrier layer is not joined to the top layer, whereby a cavity that is enclosed on all sides is formed. Within the web there is at least one perforation line. The disadvantage of this approach is that a childproof packaging is only obtained for packaging paired films (forms of administration in film form). Although the opening of the childproof seal to expose one form of administration still leaves the other form of administration packed in a chemically sealed manner, the childproof seal is no longer present. To this extent, the use of a packaging according to DE 10 2006 041 921 A1 is only appropriate if the interval between taking the first single dose and taking the second single dose is not too great.
In the case of the foil packagings known from DE 10 2004 047 445 A1, US 2006/0023976 A1 and DE 10 2006 041 921 A1, the object of providing a childproof packaging which at the same time offers protection for the packaged product from chemical impairment is achieved by the use of a peelable pouch produced by heat sealing from two foils which respectively contain a thin aluminum layer. The foil packagings have a laterally applied cut, which however does not cut the side of the pouch itself. As a result, the pouch must be folded in the middle of the cut beyond an angle of 90° in order to produce a tearing notch in the side of the peripheral edge of the pouch. This exposes an opening aid for being gripped, with the aid of which the two foils of the pouch can be peeled from one another.
The solutions described above have in common that they are based on peelable foils, i.e. the laminate layer of the foil structure that is in contact with the product must be peelable and allow itself to be detached relatively easily from the layers lying thereover. These layers are virtually always polyethylene-based peeling layers or similar compositions that have a relatively weak sealing seam strength (are therefore peelable).
In addition, these foils have the disadvantage that they are often not inert with respect to active substance migration, which has the consequence that, in the course of the storage time, the active substances migrate into the packaging, and are consequently extracted from the drug. In terms of use, the sealing seam strength is usually also weakened by the sealed polymers being weakened by incorporation of other auxiliaries that are not weldable. As a side effect, these auxiliaries also cause reduced sealing seam impermeabilities for gases such as water vapor and oxygen, which may impair the storage stability of the packaging and lead to problems due to water absorption of hygroscopic products, as well as to increased degradation of oxygen-sensitive products.
Furthermore, the material consumption for producing the packaging is further increased by the opening of the packaging requiring the presence of non-sealed portions, which serve as a gripping aid for the “peeling”, the minimum size of the gripping aids being limited by anatomical conditions.
The packaging of drugs/forms of administration in film or foil form consequently presents a particular challenge, since films and foils react sensitively to physical-chemical (for example light, moisture or oxygen) and mechanical loads.
Even if the packaging of individual forms of administration in film or foil form meets the requirements for the protection of the individually packaged product, it has the disadvantage that it is very expensive in practical implementation, because it requires high material use and the corresponding packagings can only be produced comparatively slowly.
The object of the present invention is to provide a childproof single-dose packaging for forms of administration in film or foil form and for transdermal therapeutic systems (TTSs) on the basis of sealed foils that ensures minimal foil consumption per single dose, is inert with respect to the packaged product, is easy to open and nevertheless has a maximum impermeability of the sealing seam.
It is also an object of the present invention to provide a method for producing single-dose packagings according to the present invention.